Randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke.
ABSTRACT: Background: measure the efficacy of exhaled carbon monoxide (CO) measurement plus brief advisory sessions to reduce smoking exposure and smoking behaviour in kidney transplant recipients. Methods: Randomized, controlled, open-label clinical trial at a Spanish hospital.Smoking kidney transplant recipients giving their consent to participate were randomized to control (brief advice, n=63) or intervention group (brief advisory session plus measuring exhaled CO, n=59). Measurements: Sociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smoking, drug use, level of dependence and motivation to stop smoking (Fagerström's and Richmond's test) and stage of change (Prochaska and DiClemente's Stages). Efficacy was assessed at 3, 6, 9 and 12 months as: cotinine test, CO levels in exhaled air, nicotine dependence, motivational stages of change, motivation to stop smoking, pattern of tobacco use and smoking cessation rates. Logistic regression models were computed. Results: At 12 months of follow-up, differences were found in exhaled CO between the intervention and control group(6.1±6.8vs.10.2±9.7ppm;p=0.028). Carboxyhemoglobin levels were lower in the intervention group as well as the positive cotinine test (1.2±1.2%vs.2.0±2.4%;p=0.039),(53.4%vs.74.2%). At 12 months, intervention reduces the probability of a positive urine test by 28%. Conclusions: Co-oximetry is a clinically relevant intervention for reduction of tobacco exposure in kidney transplant recipients.
Project description: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.a randomized, controlled, open clinical trial with blinded evaluation.A Coruña Hospital (Spain), reference to renal transplantation in the period 2012-2015.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.smokers attempting to stop smoking, patients with terminal illness or mental disability that prevents them from participating.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 %.sociodemographic 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).the 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).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.informed consent of the patients and Ethical Review Board was obtained (code 2011/061).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.Current Controlled Trials ISRCTN16615772 . EudraCT number: 2015-002009-12.
Project description:BACKGROUND:Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and health care costs while improving the quality of life. However, there are few effective interventions aimed at providing self-management support after kidney transplantation. OBJECTIVE:This study aims to systematically develop a nurse-led, self-management (support) intervention for kidney transplant recipients. METHODS:The Intervention Mapping protocol was used to develop an intervention that incorporates kidney transplant recipients' and nurses' needs, and theories as well as evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, Self-Regulation Theory, and the "5A's" model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Then, program materials and protocols were developed accordingly (step 4). The implementation to test the feasibility and acceptability was scheduled for 2015-2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention, falls outside the scope of this paper (step 6). RESULTS:The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both kidney transplant recipients and nurse practitioners who delivered the intervention. The intervention was clustered into four 15-minute sessions that were combined with regular appointments at the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy and Motivational Interviewing; this entailed guiding the patients to generate their own goals and solutions and focus on strengths and successes. Kidney transplant recipients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans, and pursuit skills to solve these challenges. CONCLUSIONS:The Intervention Mapping protocol provided a rigorous framework to systematically develop a self-management intervention in which nurses and kidney transplant recipients' needs, evidence-based methods, and theories were integrated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11856.
Project description:Implementation of evidence-based interventions for smoking during pregnancy is challenging. We developed 2 highly replicable interventions for smoking during pregnancy: (a) a computer-delivered 5As-based brief intervention (CD-5As) and (b) a computer-assisted, simplified, and low-intensity contingency management (CM-Lite).A sample of 110 primarily Black pregnant women reporting smoking in the past week were recruited from prenatal care clinics and randomly assigned to CD-5As (n = 26), CM-Lite (n = 28), CD-5As plus CM-Lite (n = 30), or treatment as usual (n = 26). Self-report of smoking, urine cotinine, and breath CO were measured 10 weeks following randomization.Participants rated both interventions highly (e.g., 87.5% of CD-5As participants reported increases in likelihood of quitting), but most CM-Lite participants did not initiate reinforcement sessions and did not show increased abstinence. CD-5As led to increased abstinence as measured by cotinine (43.5% cotinine negative vs. 17.4%; odds ratio [OR] = 10.1, p = .02) but not for CO-confirmed 7-day point prevalence (30.4% abstinent vs. 8.7%; OR = 5.7, p = .06). Collapsing across CM-Lite status, participants receiving the CD-5As intervention were more likely to talk to a doctor or nurse about their smoking (60.5% vs. 30.8%; OR = 3.0, p = .02).Low-intensity participant-initiated CM did not affect smoking in this sample, but the CD-5As intervention was successful in increasing abstinence during pregnancy. Further research should seek to replicate these results in larger and more diverse samples. Should CD-5As continue to prove efficacious, it could greatly increase the proportion of pregnant smokers who receive an evidence-based brief intervention.
Project description:Cigarette smoking affects many organs. It causes vasoconstriction through activation of sympathetic nervous system which leads to elevation of blood pressure and reduction in glomerular filtration rate and filtration pressure. It also causes thickening of renal arterioles. Cigarette smoking increases the risk of microalbuminuria and accelerates progression of microalbuminuria to macroalbuminuria. Furthermore, it causes rapid loss of glomerular filtration rate in chronic kidney disease patients. After kidney donation, these factors may be injurious to the solitary kidney. Kidney donors with history of cigarette smoking are prone to develop perioperative complications, pneumonia, and wound infection. Postkidney transplantation various stressors including warm and cold ischemia time, delayed graft function, and exposure to calcineurin inhibitors may result in poor graft function. Continuation of cigarette smoking in kidney transplant recipients will add further risk. In this review, we will specifically discuss the effects of cigarette smoking on normal kidneys, live kidney donors, and kidney transplant recipients. This will include adverse effects of cigarette smoking on graft and patient survival, cardiovascular events, rejection, infections, and cancers in kidney transplant recipients. Lastly, the impact of kidney transplantation on behavior and smoking cessation will also be discussed.
Project description:Confirming abstinence during smoking cessation clinical trials is critical for determining treatment effectiveness. Several biological methods exist for verifying abstinence (e.g., exhaled carbon monoxide [CO], cotinine), and while cotinine provides a longer window of detection, it is not easily used in trials involving nicotine replacement therapy. The Society for Research on Nicotine and Tobacco's Subcommittee on Biochemical Verification cite 8-10 parts per million (ppm) for CO as a viable cutoff to determine abstinence; however, recent literature suggests this cutoff is likely too high and may overestimate the efficacy of treatment.This study examined the relationship between CO and cotinine in a sample of 662 individuals participating in a smoking cessation clinical trial. A receiver operating characteristics curve was calculated to determine the percentage of false positives and false negatives at given CO levels when using cotinine as confirmation of abstinence. Differences were also examined across race and gender.A CO cutoff of 3 ppm (97.1% correct classification) most accurately distinguished smokers from nonsmokers. This same cutoff was accurate for both racial and gender groups. The standard cutoffs of 8 ppm (14.0% misclassification of smokers as abstainers) and 10 ppm (20.6% misclassification of smokers as abstainers) produced very high false-negative rates and inaccurately identified a large part of the sample as being abstinent when their cotinine test identified them as still smoking.It is recommended that researchers and clinicians adopt a more stringent CO cutoff in the range of 3-4 ppm when complete abstinence from smoking is the goal.
Project description:Background:Most smoke-free legislation to reduce secondhand smoke (SHS) exposure exempts waterpipe (hookah) smoking venues. Few studies have examined SHS exposure in waterpipe venues and their employees. Methods:We surveyed 276 employees of 46 waterpipe tobacco venues in Istanbul, Moscow, and Cairo. We interviewed venue managers and employees and collected biological samples from employees to measure exhaled carbon monoxide (CO), hair nicotine, saliva cotinine, urine cotinine, urine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and urine 1-hydroxypyrene glucuronide (1-OHPG). We estimated adjusted geometric mean ratios (GMR) of each SHS biomarker by employee characteristics and indoor air SHS measures. Results:There were 73 nonsmoking employees and 203 current smokers of cigarettes or waterpipe. In nonsmokers, the median (interquartile) range concentrations of SHS biomarkers were 1.1 (0.2, 40.9) µg/g creatinine urine cotinine, 5.5 (2, 15) ng/mL saliva cotinine, 0.95 (0.36, 5.02) ng/mg hair nicotine, 1.48 (0.98, 3.97) pg/mg creatinine urine NNAL, 0.54 (0.25, 0.97) pmol/mg creatinine urine 1-OHPG, and 1.67 (1.33, 2.33) ppm exhaled CO. An 8-hour increase in work hours was associated with higher urine cotinine (GMR: 1.68, 95% CI: 1.20, 2.37) and hair nicotine (GMR: 1.22, 95% CI: 1.05, 1.43). Lighting waterpipes was associated with higher saliva cotinine (GMR: 2.83, 95% CI: 1.05, 7.62). Conclusions:Nonsmoking employees of waterpipe tobacco venues were exposed to high levels of SHS, including measurable levels of carcinogenic biomarkers (tobacco-specific nitrosamines and PAHs). Implications:Smoke-free regulation should be extended to waterpipe venues to protect nonsmoking employees and patrons from the adverse health effects of SHS.
Project description:Importance:Clinicians have an opportunity to provide smoking cessation interventions to smokers who present to emergency departments (EDs). The effectiveness of a brief intervention based on self-determination theory for smoking cessation is uncertain. Objective:To examine the effectiveness of a brief intervention based on self-determination theory for smoking cessation (immediate or progressive) among Chinese smokers presenting at EDs in Hong Kong. Design, Setting, and Participants:This single-blind, multicenter intent-to-treat randomized clinical trial was conducted at the EDs of 4 major acute care hospitals in different districts of Hong Kong. In total, 1571 smokers 18 years or older who presented at 4 major EDs between July 4, 2015, and March 17, 2017, were randomized into an intervention group (n?=?787) and a control group (n?=?784). Interventions:The intervention group received brief advice (about 1 minute) and could choose their own quit schedules (immediate or progressive). The control group received a smoking cessation leaflet. Main Outcomes and Measures:Follow-up visits were conducted at 1, 3, 6, and 12 months. The primary outcome measure, by intent to treat, was biochemically validated abstinence at 6 months. Results:Participants (N?=?1571) included 1381 men (87.9%); the mean (SD) age at baseline was 47.4 (16.4) years. Among participants who self-reported abstinence at 6 months, 50.3% (85 of 169) had biochemical validation by both an exhaled carbon monoxide test and a saliva cotinine test. Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P?<?.001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P?<?.001). The intervention group also had higher self-reported quit rates at 6 months (12.2% [96 of 787] vs 9.3% [73 of 784], P?=?.04) and 12 months (13.0% [102 of 787] vs 8.5% [67 of 784], P?<?.01), as well as higher biochemically validated abstinence at 12 months (7.0% [55 of 787] vs 3.7% [29 of 784], P?<?.001). The additional cost for each intervention group participant was US $0.47, with an estimated gain of 0.0238 quality-adjusted life-year. The incremental cost per quality-adjusted life-year (US $19.53) fell within acceptable thresholds. Conclusions and Relevance:This brief, low-cost self-determination theory-based intervention for smokers presenting at EDs effectively increased the biochemically validated quit rate at 6 months. If delivered routinely, such a simple intervention may offer a cost-effective and sustainable approach to help many smokers quit smoking. Trial Registration:ClinicalTrials.gov identifier: NCT02660957.
Project description:There is a lack of data analyzing the influence of cardiovascular disease (CVD) risk factor control on graft survival disparities in African-American kidney transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in African-Americans, leading to higher rates of renal failure and major acute cardiovascular events. However, with the exception of hypertension, there is no data demonstrating similar results within transplant recipients. Recent analyses conducted by our investigator group indicate that CVD risk factors, especially diabetes, are poorly controlled in African-American recipients, which likely impacts graft loss. This study protocol describes a prospective interventional clinical trial with the goal of demonstrating improved medication safety and CVD risk factor control in adult solitary kidney transplant recipients at least one-year post-transplant with a functioning graft. This is a prospective, interventional, 6-month, pharmacist-led and technology enabled study in adult kidney transplant recipients with the goal of improving CVD risk factor outcomes by improving medication safety and patient self-efficacy. This papers describes the issues related to racial disparities in transplant, the details of this intervention and how we expect this intervention to improve CVD risk factor control in kidney transplant recipients, particularly within African-Americans.
Project description:A brief "Lung Age" feedback intervention has shown promise for personalizing the health impact of smoking and promoting cessation in unselected smokers. Now that many healthcare organizations provide face-to-face cessation services, it is reasonable to ask whether such motivational feedback of lung function tests might improve treatment compliance and cessation rates in smokers wanting to quit. This study assessed effects of baseline motivational spirometry-based "Lung Age" feedback on treatment compliance and tobacco abstinence at 28-day follow-up.This randomized controlled pilot study took place in Penn State University-affiliated outpatient medical practices. Participants were 225 adult smokers (?5 cigarettes/day) willing to attend tobacco dependence treatment. At assessment lung function (FEV-1) and exhaled carbon-monoxide (CO) were assessed. The Intervention group (n=120) were randomly allocated to receive motivational "Lung Age" feedback estimated by FEV-1 and on exhaled CO; Control group (n=105) received minimal feedback. Participants were offered 6 weekly group smoking cessation sessions and nicotine patches and followed-up 28 days after target quit date. The primary outcome measure was self-reported 7-day tobacco abstinence, confirmed by CO<10ppm at 28-day follow-up.Quit rates were similar at follow-up (Intervention 50.8%; Control 52.4%; p=0.65) after controlling for abstinence predictors. Group attendance and patch use were similar. Among those attending follow-up (n=164, 73%), a greater proportion of the Intervention group had improved lung function (67% vs. 46%; p=0.0083).Baseline Lung Age feedback did not improve quit rates or compliance at 28-day follow-up in smokers seeking intensive treatment.
Project description:Background:Post-transplant weight gain affects 50-90% of kidney transplant recipients adversely affecting survival, quality of life, and risk for diabetes and cardiovascular disease. Diet modification and physical activity may help prevent post-transplant weight gain. Methods for effective implementation of these lifestyle modifications are needed. The objective of this study is to assess the feasibility and acceptability of a remotely delivered nutrition and physical activity intervention among kidney transplant recipients. Secondary aims were to estimate the effectiveness of the intervention in producing changes in physical activity, qualify of life, fruit and vegetable intake, and consumption of whole grains and water from baseline to 6 months. Methods:A randomized controlled study for stable kidney transplant recipients between 6 and 12 months post-transplantation was conducted. Participants were randomly assigned 1:1 to a technology-based, lifestyle modification program (intervention) or to enhanced usual care (control). Results:The first 10 kidney transplant recipients screened were eligible and randomized into the intervention and control groups with no significant between-group differences at baseline. Health coaching attendance (78%) and adherence to reporting healthy behaviors (86%) were high. All participants returned for final assessments. The weight in controls remained stable, while the intervention arm showed weight gain at 3 and 6 months. Improvements were found for physical activity, quality of life, and fruit and vegetable intake in both groups. All participants would recommend the program to other transplant recipients. Conclusions:Our data suggest that a remotely delivered televideo nutrition and physical activity intervention is feasible and valued by patients. These findings will aid in the development of a larger, more prescriptive, randomized trial to address weight gain prevention. Trial registration:Clinicaltrials.gov Identifier NCT03697317. Retrospectively registered on October 5, 2018.