• Salvador Pita-Fernández, Rocío Seijo-Bestilleiro, Sonia Pértega-Díaz, Ángel Alonso-Hernández, Constantino Fernández-Rivera, Mercedes Cao-López, Teresa Seoane-Pillado, Beatriz López-Calviño, Cristina González-Martín, and Francisco Valdés-Cañedo.
• Clinical Epidemiology and Biostatistics Unit, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), SERGAS, Universidade da Coruña, Hotel de Pacientes, 7a, As Xubias, 84, 15006, A Coruña, Spain. salvador.pita.fernandez@sergas.es.
• Trials. 2016 Apr 1; 17: 174.

BackgroundThe cardiovascular risk in renal transplant patients is increased in patients who continue to smoke after transplantation. The aim of the study is to measure the effectiveness of exhaled carbon monoxide (CO) measurement plus brief advisory sessions, in comparison to brief advice, to reduce smoking exposure and smoking behavior in kidney transplant recipients who smoke. The effectiveness will be measured by: (1) abandonment of smoking, (2) increase in motivation to stop smoking, and (3) reduction in the number of cigarettes smoked per day.Methods/DesignDesigna randomized, controlled, open clinical trial with blinded evaluation.ScopeA Coruña Hospital (Spain), reference to renal transplantation in the period 2012-2015.Inclusion Criteriarenal transplant patients who smoke in the precontemplation, contemplation or preparation stages according to the Prochaska and DiClemente's Stages of Change model, and who give their consent to participate.Exclusion Criteriasmokers attempting to stop smoking, patients with terminal illness or mental disability that prevents them from participating.Randomizationpatients will be randomized to the control group (brief advisory session) or the intervention group (brief advisory session plus measuring exhaled CO). The sample target size is n = 112, with 56 patients in each group. Allowing for up to 10 % loss to follow-up, this would provide 80 % power to detect a 13 % difference in attempting to give up smoking outcomes at a two-tailed significance level of 5 %.Measurementssociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smoking habit, drug use, level of dependence (the Fagerström test), stage of change (Prochaska and DiClemente's Stages of Change model), and motivation to giving up smoking (the Richmond test).Responsethe effectiveness will be evaluated every 3, 6, 9 and 12 months as: pattern of tobacco use (self-reported tobacco use), smoking cessation rates, carbon monoxide (CO) levels in exhaled air measured by CO-oximetry, urinary cotinine tests, nicotine dependence (Fagerström test), motivational stages of change (Prochaska and DiClemente's stages) and motivation to stop smoking (the Richmond test).Analysisdescriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.Ethicsinformed consent of the patients and Ethical Review Board was obtained (code 2011/061).DiscussionTobacco is a modifiable risk factor that increase the risk of morbidity and mortality in kidney transplant recipients. If effectiveness of CO-oximetry is confirmed to reduce tobacco exposure, we would have an intervention that is easy to use, low cost and with great implications about cardiovascular risk prevention in these patients.Trial RegistrationCurrent Controlled Trials ISRCTN16615772 . EudraCT number: 2015-002009-12.

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