一个随机临床试验来确定在吸烟肾移植患者队列中CO-血氧饱和度和禁烟的简短建议的有效性：一个随机对照试验的研究方案
2016/06/20
摘要
背景：在移植后继续吸烟的患者中，肾移植患者的心血管风险增加。本研究的目的是，评估检测呼出一氧化碳（CO）加上简短的劝告的有效性，并与简短建议相比较4，来降低肾移植吸烟受试者的吸烟暴露和吸烟行为。检测的有效性包括：（1）放弃吸烟，（2）增加戒烟的动机，和（3）减少每天吸烟的数量。
方法/设计：一个有盲法评价的随机的、对照的、开放的临床试验。
范围：Coruña医院（西班牙），在2012-2015年期间肾移植。
纳入标准：根据Prochaska and DiClemente's的阶段改变模式，肾移植患者吸烟在未考虑阶段、考虑阶段或者准备阶段吸烟，并且自愿参加研究的患者。
排除标准：吸烟者试图戒烟、病人有绝症或有阻碍他们参加的精神疾病。
随机化：将患者随机分为对照组（简短建议）或干预组（简短建议加测量CO呼出量）。样本目标大小为n = 112，每组56例。允许随访时多达10%的损失，这将提供80%的功率来检测13%的差异，来试图放弃在双尾5%的显著性水平的吸烟结果 。
测量： 社会人口学特征、心血管危险因素、治疗、排斥反应、感染、自述的抽烟习惯、用药、依赖水平（Fagerström测试）、改变阶段（Prochaska and DiClemente's 的阶段变化模型）和戒烟动机（Richmond测试）。
反馈：每3、6、9个月和12个月进行有效性评估：烟草使用模式（自述的烟草使用）、戒烟率、CO血氧饱和度为指标的呼出气体中的一氧化碳（CO）水平、尿液可铁宁测试、尼古丁依赖（Fagerström 试验）、改变的动机阶段（Prochaska and DiClemente's阶段）和戒烟动机（Richmond测试）。
分析：将采用描述性统计和线性/逻辑多变量回归模型。使用降低的相对风险、绝对风险和需被治疗的数量来衡量临床相关性。
伦理：获得了患者和伦理审查委员会的知情同意（代码2011/061)
讨论：烟草可以提高肾移植患者的发病和死亡的风险，这一危险因素是可以改变的。如果CO血氧饱和度的有效性被证实可减少烟草接触，我们将获得一项使用方便、成本低、对这些患者的心血管风险防范有很大影响的干预方法。
（苏欣 审校）
Trials. 2016 Apr 1;17(1):174. doi: 10.1186/s13063-016-1311-7.
A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial.
Pita-Fernández S1, Seijo-Bestilleiro R2, Pértega-Díaz S2, Alonso-Hernández Á3, Fernández-Rivera C3, Cao-López M3, Seoane-Pillado T2, López-Calviño B2, González-Martín C4, Valdés-Cañedo F3.
Author information
Abstract
BACKGROUND:The 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/DESIGN:a randomized, controlled, open clinical trial with blinded evaluation.
SCOPE:A Coruña Hospital (Spain), reference to renal transplantation in the period 2012-2015.
INCLUSION CRITERIA:renal 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 CRITERIA: smokers attempting to stop smoking, patients with terminal illness or mental disability that prevents them from participating.
RANDOMIZATION: patients 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 %.
MEASUREMENTS: sociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smokinghabit, 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).
RESPONSE: the effectiveness will be evaluated every 3, 6, 9 and 12 months as: pattern of tobacco use (self-reported tobacco use), smokingcessation 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).
ANALYSIS: descriptive 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.
ETHICS: informed consent of the patients and Ethical Review Board was obtained (code 2011/061).
DISCUSSION: Tobacco 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 REGISTRATION: Current Controlled Trials ISRCTN16615772 . EudraCT number: 2015-002009-12.
KEYWORDS: Carbon monoxide; Kidney transplantation; Nicotine dependence; Smoking cessation
Trials. 2016 Apr 1;17(1):174. doi: 10.1186/s13063-016-1311-7.
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外科医生和病人对术前戒烟的行为、认识和态度
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美国年轻人戒烟的原因和障碍
