N Safdar1, R Zahid1, S Shah2, R Fatima3, I Cameron4, K Siddiqi2. 1. Social and Health Inequalities Network (SHINe), Islamabad, Pakistan. 2. Department of Health Sciences, University of York, UK. 3. National TB Programme, Islamabad, Pakistan. 4. Leeds City Council, Leeds, UK.
Abstract
BACKGROUND: Passive smoking is associated with tuberculosis (TB). Measures are required to protect non-smoking TB patients from second-hand smoke (SHS). SETTING: We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. OBJECTIVES: To assess the likelihood of such an intervention being successful and to inform a definitive trial in future. DESIGN: This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individual-based support combined with family reminders. We recruited patients living with at least one smoker in their homes. Our primary outcome was urinary cotinine level as a measure of SHS exposure 2 months post-randomisation. RESULTS: Of 273 patients assessed for eligibility, 150 (56%) patients were recruited and all but one were retained throughout the trial. A statistically significant absolute reduction was observed in non-smoking participants' exposure to SHS based on urinary cotinine levels in both Arm 1 (71%, 95%CI 61-79) and Arm 2 (76%, 95%CI 67-83) between baseline and follow-up at 2 months. CONCLUSIONS: The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future. The observed effect size makes it worthwhile to conduct such a trial.
RCT Entities:
BACKGROUND: Passive smoking is associated with tuberculosis (TB). Measures are required to protect non-smoking TB patients from second-hand smoke (SHS). SETTING: We developed a behavioural intervention to encourage TB patients to implement smoking restrictions at home in Pakistan. OBJECTIVES: To assess the likelihood of such an intervention being successful and to inform a definitive trial in future. DESIGN: This was a pilot randomised controlled trial in which non-smoking TB patients were randomised to receive either individual-based support or individual-based support combined with family reminders. We recruited patients living with at least one smoker in their homes. Our primary outcome was urinary cotinine level as a measure of SHS exposure 2 months post-randomisation. RESULTS: Of 273 patients assessed for eligibility, 150 (56%) patients were recruited and all but one were retained throughout the trial. A statistically significant absolute reduction was observed in non-smoking participants' exposure to SHS based on urinary cotinine levels in both Arm 1 (71%, 95%CI 61-79) and Arm 2 (76%, 95%CI 67-83) between baseline and follow-up at 2 months. CONCLUSIONS: The recruitment and retention rates for trial participants make it feasible to conduct a definitive trial in future. The observed effect size makes it worthwhile to conduct such a trial.
Authors: Sandra M Eldridge; Gillian A Lancaster; Michael J Campbell; Lehana Thabane; Sally Hopewell; Claire L Coleman; Christine M Bond Journal: PLoS One Date: 2016-03-15 Impact factor: 3.240