Use of additional nicotine replacement therapy by participants in a five-year follow-up of a tobacco cessation trial.

INTRODUCTION: Using data from an extended follow-up of a randomized trial of mailed nicotine patches, the current secondary analysis explores the continued level of interest in nicotine replacement therapy (NRT) as a means to promote tobacco cessation and whether the purchase of additional NRT was related to tobacco cessation. METHODS: Attempts were made to re-contact participants (N = 999) from a randomized trial of mailed nicotine patches to take part in a five-year follow-up. Those contacted were asked about their current smoking status, interest in free-of-charge NRT, and purchase of other NRT in the time since the 6-month follow-up. RESULTS: A total of 518 participants were successfully interviewed at the five-year time point. While 43.6% of these participants purchased additional NRT, this purchase was unrelated to success at tobacco cessation or to initial group randomization (received/did not received nicotine patches at baseline). Current smokers reported continued interest in receiving free-of charge NRT (77.2% were interested). Participants in the intervention group who reported using all of the nicotine patches they received at baseline (31.8%) were more likely to report purchasing additional NRT (54.9% versus 39.1%; p = .02) and to report not currently smoking at the five-year follow-up (46.2% versus 27.2%; p = .006) compared to those who used some or none of the nicotine patches mailed to them. CONCLUSIONS: The present study found no consistent evidence that NRT is related to long-term success at tobacco cessation. Smokers remain interested in NRT as a means to help them quit smoking.

Assessing the quality of clinical and administrative data extracted from hospitals: the General Medicine Inpatient Initiative (GEMINI) experience.

OBJECTIVE: Large clinical databases are increasingly used for research and quality improvement. We describe an approach to data quality assessment from the General Medicine Inpatient Initiative (GEMINI), which collects and standardizes administrative and clinical data from hospitals. METHODS: The GEMINI database contained 245 559 patient admissions at 7 hospitals in Ontario, Canada from 2010 to 2017. We performed 7 computational data quality checks and iteratively re-extracted data from hospitals to correct problems. Thereafter, GEMINI data were compared to data that were manually abstracted from the hospital's electronic medical record for 23 419 selected data points on a sample of 7488 patients. RESULTS: Computational checks flagged 103 potential data quality issues, which were either corrected or documented to inform future analysis. For example, we identified the inclusion of canceled radiology tests, a time shift of transfusion data, and mistakenly processing the chemical symbol for sodium ("Na") as a missing value. Manual validation identified 1 important data quality issue that was not detected by computational checks: transfusion dates and times at 1 site were unreliable. Apart from that single issue, across all data tables, GEMINI data had high overall accuracy (ranging from 98%-100%), sensitivity (95%-100%), specificity (99%-100%), positive predictive value (93%-100%), and negative predictive value (99%-100%) compared to the gold standard. DISCUSSION AND CONCLUSION: Computational data quality checks with iterative re-extraction facilitated reliable data collection from hospitals but missed 1 critical quality issue. Combining computational and manual approaches may be optimal for assessing the quality of large multisite clinical databases.

Modelling resource requirements and physician staffing to provide virtual urgent medical care for residents of long-term care homes: a cross-sectional study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) outbreak increases the importance of strategies to enhance urgent medical care delivery in long-term care (LTC) facilities that could potentially reduce transfers to emergency departments. The study objective was to model resource requirements to deliver virtual urgent medical care in LTC facilities. METHODS: We used data from all general medicine inpatient admissions at 7 hospitals in the Greater Toronto Area, Ontario, Canada, over a 7.5-year period (Apr. 1, 2010, to Oct. 31, 2017) to estimate historical patterns of hospital resource use by LTC residents. We estimated an upper bound of potentially avoidable transfers by combining data on short admissions (≤ 72 h) with historical data on the proportion of transfers from LTC facilities for which patients were discharged from the emergency department without admission. Regression models were used to extrapolate future resource requirements, and queuing models were used to estimate physician staffing requirements to perform virtual assessments. RESULTS: There were 235 375 admissions to general medicine wards, and residents of LTC facilities (age 16 yr or older) accounted for 9.3% (n = 21 948) of these admissions. Among the admissions of residents of LTC facilities, short admissions constituted 24.1% (n = 5297), and for 99.8% (n = 5284) of these admissions, the patient received laboratory testing, for 86.9% (n = 4604) the patient received plain radiography, for 41.5% (n = 2197) the patient received computed tomography and for 81.2% (n = 4300) the patient received intravenous medications. If all patients who have short admissions and are transferred from the emergency department were diverted to outpatient care, the average weekly demand for outpatient imaging per hospital would be 2.6 ultrasounds, 11.9 computed tomographic scans and 23.9 radiographs per week. The average daily volume of urgent medical virtual assessments would range from 2.0 to 5.8 per hospital. A single centralized virtual assessment centre staffed by 2 or 3 physicians would provide services similar in efficiency (measured by waiting time for physician assessment) to 7 separate centres staffed by 1 physician each. INTERPRETATION: The provision of acute medical care to LTC residents at their facility would probably require rapid access to outpatient diagnostic imaging, within-facility access to laboratory services and intravenous medication and virtual consultations with physicians. The results of this study can inform efforts to deliver urgent medical care in LTC facilities in light of a potential surge in COVID-19 cases.

Correction to: Self-Directed Gambling Changes: Trajectory of Problem Gambling Severity in Absence of Treatment.

The original version of this article unfortunately contained errors in the Methods section. The citations blinded during the review process were inadvertently omitted during the production process and subsequent stages.

Randomized controlled trial of an Internet intervention for problem gambling provided with or without access to an Internet intervention for co-occurring mental health distress.

BACKGROUND AND AIMS: The current randomized controlled trial tested whether there was benefit to providing an online gambling intervention and a separate self-help mental health intervention for anxiety and depression (i.e. MoodGYM) (G + MH), compared to only a gambling intervention (G only) among people with co-occurring gambling problems and mental health distress. The primary outcome of interest was improvement in gambling outcomes. Secondary analyses also tested for the impact of the combined intervention on depression and anxiety outcomes. METHODS: Participants who were concerned about their gambling were recruited to help evaluate an online intervention for gamblers. Those who met criteria for problem gambling were randomized to receive either the G only or the G + MH intervention. Participants were also assessed for current mental health distress at baseline, with three quarters (n = 214) reporting significant current distress and form the sample for this study. Participants were followed-up at 3- and 6-months to assess changes in gambling status, and improvements in depression and anxiety. RESULTS: Follow-up rates were poor (47% completed at least one follow-up). While there were significant reductions in gambling outcomes, as well as on measures of current depression and anxiety, there was no significant difference in outcomes between participants receiving the G only versus the G + MH intervention. DISCUSSION AND CONCLUSION: There does not appear to be a benefit to providing access to an additional online mental health intervention to our online gambling intervention, at least among participants who are concerned about their gambling.Trial registration: ClinicalTrials.govNCT02800096; Registration date: June 14, 2016.

To send or not to send: weighing the costs and benefits of mailing an advance letter to participants before a telephone survey.

OBJECTIVE: A letter was mailed to half the participants (Letter = 137; No Letter = 138) of a 5-year follow-up survey regarding smoking cessation before attempting contact for a telephone interview. The primary outcome was the number of completed surveys per group (response rate). Secondary analyses of the number of telephone calls placed and a cost analysis were performed. RESULTS: No conclusive effect was found on the response rates per group (59.1% Letter, 50.0% No Letter; p = 0.147). Additionally, a logistic regression, controlling for demographics, revealed that there was no direct effect of sending the letter on response rate (p = 0.369). Non-parametric analysis showed significantly fewer calls (U = 7962.5, z = - 2.274, p < 0.05 two-tailed) and significantly lower costs (U = 11112.00, z = 2.521, p < 0.05 two-tailed) in reaching participants in the Letter group. Mailing an advance letter to participants did not appear to effect response rates between the groups, even when controlling for demographics. However, further analysis examining the number of call attempts and the costs per group revealed the letter may have had other effects. These findings suggest that additional analyses may be merited when evaluating the effectiveness of methods to increase participation, such as an advance letter, especially in cases where the literature largely supports its effectual use. Trial registration ClinicalTrials.gov NCT03097445. Registered 31 March 2017.

Betting on Life: Associations Between Significant Life Events and Gambling Trajectories Among Gamblers with the Intent to Quit.

Considerable evidence has suggested that problem gambling may be transitory and episodic, with gamblers routinely moving in and out of clinical thresholds. Findings in qualitative and quantitative studies have converged on identifying preliminary evidence for the role of life events as motivators and contributing factors for gambling changes over time. The aim of this study was to conduct an exploratory analysis of the relationship between life events, their respective experience as positive or negative, and gambling trajectories among problem gamblers intending to quit. Life event occurrence and ratings as positive or negative, and changes in gambling severity were analyzed over a 12-month period for 204 adult problem gamblers intending to reduce or quit their gambling. Overall, mixed effects models revealed several relationships between life events and both the magnitude and direction of gambling change over time. In particular, gamblers who experienced a greater number of positive events or specific events such as legal events, the adoption/loss of a child, or negative changes to their social relationships, finances, work environments or social/health activities were more likely to exhibit greater gambling reductions over time. Conversely, gamblers who experienced a greater number of negative events, such as family bereavement, the dissolution of a marriage, or negative changes to their residence exhibited smaller gambling reductions or increases in gambling severity. Possible mechanisms which may explain the findings and the importance of examining the subjective experience of life events are discussed. Recommendations for future studies examining associations between life events and gambling trajectories are provided.

Self-Directed Gambling Changes: Trajectory of Problem Gambling Severity in Absence of Treatment.

Most problem gamblers do not seek formal treatment, recovering on their own through cognitive re-appraisal or self-help strategies. Although barriers to treatment have been extensively studied, there is a paucity of research on self-directed changes in problem gambling and very few studies have examined these changes prospectively. The aim of this study was to examine the trajectory of gambling severity and behavior change over an 18-month period, among a sample of non-treatment seeking/attending problem gamblers recruited from the community (N = 204) interested in quitting or reducing gambling. Separate mixed effects models revealed that in absence of formal treatment, significant reductions in gambling severity, frequency, and amount gambled could be observed over the course of a 6 to 9-month period and that changes experienced within the first 12 months were maintained for an extended 6 months. Problem gambling severity at baseline was significantly associated with changes in severity over time, such that participants with more severe gambling problems demonstrated greater reductions in their gambling severity over time. A total of 11.1% of participants gambled within a low-risk threshold at 18 months, although 28.7% of the sample reported consecutive gambling severity scores below problem levels for the duration of 1 year or longer. The findings suggest that among problem gamblers motivated to quit or reduce their gambling, significant self-directed changes in gambling severity can occur over a relatively short time. Additional prospective studies are needed to document the role of specific self-help tools or thought processes in exacting gambling changes.

Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption.

BACKGROUND: Mechanical Turk (MTurk) is an online portal operated by Amazon where 'requesters' (individuals or businesses) can submit jobs for 'workers.' MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. METHODS: Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107). The same basic recruitment strategy was employed for each trial - invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment), identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment), randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. RESULTS: There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status). Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. CONCLUSIONS: It is possible to recruit large (but not inexhaustible) numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

What does it mean when people say that they have received expressions of concern about their drinking or advice to cut down on the AUDIT scale?

BACKGROUND: The Alcohol Use Disorders Identification Test (AUDIT) is a commonly used scale to measure severity of alcohol consumption that contains an item asking if anyone has expressed concern about your drinking or suggested you cut down. What does it mean when a participant says yes to this question? METHODS: Participants who were 18 or older and who drank at least weekly were recruited to complete a survey about their drinking from the Mechanical Turk platform. Comparisons were made between at risk (n = 2565) and high risk drinkers (n = 581) who said that someone had expressed concern about their drinking regarding who had expressed concern. If the person expressing concern was a health professional, the participant was also asked what type of support was provided. RESULTS: Expressions of concern about drinking were received more often by high risk than at risk drinkers. The most common type of person to have expressed concern was a relative, followed by a friend, or a marital partner. About one quarter of participants had received expressions of concern from a medical doctor or other health professional. All health professionals' expressions of concern were accompanied by a suggestion to cut down and about half provided some additional support (the most common type of support was brief advice). CONCLUSIONS: Expressions of concern come from a variety of sources and the likelihood of their occurrence is partially related to amount of alcohol intake.

Impact of large-scale distribution and subsequent use of free nicotine patches on primary care physician interaction.

BACKGROUND: Large-scale distribution efforts of free nicotine replacement therapy (NRT) have been documented to be cost-effective interventions for increasing smoking quit rates. However, despite nearly a dozen studies evaluating their effectiveness, none have examined whether free NRT provision promotes further primary care help-seeking and the impact that it may have on cessation efforts. METHODS: In the context of a randomized controlled trial, a secondary analysis was conducted on 1000 adult regular smokers randomized to be mailed a 5-week supply of nicotine patches or to a no intervention control group. Recipients and users of free nicotine patches at an 8 week follow-up were successfully case matched to controls based on age, gender, baseline level of nicotine dependence and intent to quit (n = 201 per group). Differences in physician interaction between the two groups were evaluated at both 8 week and 6 month follow-ups. The impact of physician interaction on self-reported smoking abstinence at each follow-up was also examined. RESULTS: Although no differences in physician interaction were noted between groups at the 8 week follow-up, at the 6 month follow-up, nicotine patch users reported greater frequency of discussing smoking with their physician (43.9%), as compared to the control group (30.3%) (p = 0.011). Across both groups, over 90% of those that discussed smoking with a physician were encouraged to quit and approximately 70% were provided with additional support. Separate ANOVAs revealed no significant impact of physician interaction on cessation (p > 0.05), regardless of group or follow-up period, however, at the 6 month follow-up, nicotine patch users who discussed cessation with a physician had made serious quit attempts at significantly greater rates (72.6%), compared to controls (49.1%) (p = 0.007). CONCLUSIONS: Irrespective of group, the majority of smokers in the present study did not discuss cessation with their physician. Recipients and users of nicotine patches however, were more likely to discuss smoking with their physician, suggesting that the provision of free NRT particularly to those who are likely to use it may facilitate opportunities for benefits beyond the direct pharmacological effects of the medication. TRIAL REGISTRATION: clinicaltrials.gov , NCT01429129 . Registered: 2 September 2011.

Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up.

BACKGROUND: Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. METHODS/DESIGN: Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. DISCUSSION: If the study finds that the mailed distribution of free NRT is effective at promoting long-term cessation, it would provide further evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it. TRIAL REGISTRATION: ClinicalTrials.gov : NCT01429129 , Registered 2 September 2011; NCT03097445 , Registered 25 March 2017.

Mailed distribution of free nicotine patches without behavioral support: Predictors of use and cessation.

INTRODUCTION: There is growing evidence that the mailed distribution of free nicotine replacement therapy (NRT), usually as part of smokers' helplines, can been effective in increasing the odds of cessation on a population level. However, limited information is available on the utilization of NRT when it is provided for free, and factors associated with regimen adherence have remained largely unexplored. METHODS: In the context of a randomized controlled trial, 500 adult smokers across Canada hypothetically interested in free NRT were mailed a 5week supply of nicotine patches, but no other support was offered. Analyses evaluated which a priori-defined demographic and smoking characteristics predicted nicotine patch use at 8week follow-up of 421 patch recipients, as well as examined the association between patch use and smoking cessation at 6months. RESULTS: At 8weeks, 10.9% had used all, 47.5% had used some but not all, and 41.6% had not used any of the provided nicotine patches. Lower age, unemployment, past NRT use and intent to quit in the next 30days at baseline (preparation stage of change) were all identified as independent predictors of some nicotine patch use. Only use of all patches was associated with greater odds of smoking cessation, compared to non-users (Adj. OR=2.96; 95%CI=1.06-8.27). CONCLUSIONS: The mailed distribution of free nicotine patches to smokers at large can be effective at promoting cessation, particularly among financially disadvantaged groups, those with previous NRT experience and among individuals with already advanced intent to quit.

Can Amazon's Mechanical Turk be used to recruit participants for internet intervention trials? A pilot study involving a randomized controlled trial of a brief online intervention for hazardous alcohol use.

OBJECTIVES: To determine whether Amazon's Mechanical Turk (MTurk) might be a viable means of recruiting participants for online intervention research. This was accomplished by conducting a randomized controlled trial of a previously validated intervention with participants recruited through MTurk. METHODS: Participants were recruited to complete an online survey about their alcohol use through the MTurk platform. Those who met eligibility criterion for age and problem drinking were invited to complete a 3-month follow-up. Those who agreed were randomized to receive access to an online brief intervention for drinking or were assigned to a no intervention control group (i.e., thanked and told that they would be re-contacted in 3 months). RESULTS: A total of 423 participants were recruited, of which 85% were followed-up at 3-months. All participants were recruited in 3.2 h. Only 1/3 of participants asked to access the online brief intervention did so. Of the 4 outcome variables (number of drinks in a typical week, highest number on one occasion, number of consequences, AUDIT consumption subscale), one displayed a significant difference between conditions. Participants in the intervention group reported a greater reduction between on the AUDIT consumption subscale between baseline and 3-month follow-up compared to those in the no intervention control group (p = 0.004). CONCLUSIONS: Despite the current pilot showing only limited evidence of impact of the intervention among participants recruited through MTurk, there is potential for conducting trials employing this population (particularly if methods are employed to make sure that participants receive the intervention). This potential is important as it could allow for the rapid conduct of multiple trials during the development stages of online interventions.

Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers.

PURPOSE: Brief Internet interventions have been shown to reduce alcohol consumption. This trial intended to compare the effects of one such brief intervention to an extended Internet intervention for problem drinkers. METHOD: Using online advertising, 490 participants, 18 years or older, were recruited and randomized to receive a brief ( CheckYourDrinking.net ) versus an extended ( AlcoholHelpCentre.net ) Internet intervention and were followed up at 6, 12, and 24 months. The per protocol primary analysis assessed difference between condition at the 12-month follow-up. RESULTS: The follow-up rate at 12 months was 83.3 %. ANCOVAs of the primary (Alcohol Use Disorder Identification Test (AUDIT)-C) and secondary outcome variables (drinks in a typical week, highest number of drinks on one occasion-baseline drinking as covariate) revealed no significant (p > 0.05) differences between the interventions. Similarly, combined analyses of the 6-, 12-, and 24-month follow-up revealed no significant differences between interventions at all time points. CONCLUSION: The present study does not provide support for the added benefit of an extended Internet intervention for problem drinkers over a brief Internet intervention.

Impact of self-reported lifetime depression or anxiety on effectiveness of mass distribution of nicotine patches.

BACKGROUND: Large-scale public health initiatives providing free nicotine replacement therapy have been shown to increase smoking cessation rates; however, their effectiveness among the highly prevalent population of smokers with depression and anxiety disorders has not been explored. The aim of this study was to investigate the influence of lifetime history of depression or anxiety on smoking cessation success following the free distribution of nicotine patches. METHOD: In the context of a randomised controlled trial, a secondary analysis was conducted on 1000 adult regular smokers randomised to be mailed a 5-week supply of nicotine patches or to a no intervention control group. Participants were divided into subgroups based on the presence of self-reported lifetime diagnosis of depression and anxiety. RESULTS: Irrespective of self-reported lifetime history of depression or anxiety, odds of self-reported cessation at 6 months were significantly greater among groups receiving nicotine patches compared to no intervention control (no history of depression or anxiety: OR 2.20; 95% CI 1.05 to 4.63; history of depression or anxiety present: OR 3.90; 95% CI 1.28 to 11.88). Among nicotine patch recipients only, quit outcomes did not differ between those with and without self-reported lifetime depression or anxiety in models unadjusted and adjusted for differences in demographic and smoking characteristics. CONCLUSIONS: The mass distribution of free nicotine patches (without behavioural support) is effective among smokers with or without lifetime history of depression or anxiety alike, providing further support for the adoption of similar initiatives as a means of promoting tobacco cessation on a population level. TRIAL REGISTRATION NUMBER: NCT01429129, Post-results.

Effect of Mailing Nicotine Patches on Tobacco Cessation Among Adult Smokers: A Randomized Clinical Trial.

IMPORTANCE: The efficacy of nicotine replacement therapy (NRT) is well demonstrated in clinical trials in which NRT is accompanied by behavioral support. Epidemiologic data, however, indicate that people using NRT are no more likely to successfully quit smoking than those who do not use NRT. OBJECTIVE: To evaluate the effect of mailing nicotine patches to smokers without behavioral support on quit success rates. DESIGN, SETTING, AND PARTICIPANTS: A single-blinded, 2-group randomized clinical trial of adult smokers recruited across Canada by random-digit dialing of home and cell telephone numbers from June 4, 2012, through June 26, 2014. Follow-up was completed on January 5, 2015, and data were analyzed from May 24, 2015, through July 6, 2015. A total of 2093 individuals who smoked more than 10 cigarettes per day were interviewed at baseline and asked if they would be hypothetically interested in receiving nicotine patches by mail to quit smoking. Those who were interested and deemed eligible to participate (no contraindications to NRT) were randomized to the experimental group to be mailed a 5-week supply of nicotine patches or to a control group. Telephone follow-ups were conducted at 8 weeks and 6 months. INTERVENTIONS: Participants in the experimental group were sent a 5-week course of nicotine patches by expedited postal mail (3 weeks of step 1 [21 mg of nicotine], 1 week of step 2 [14 mg of nicotine], 1 week of step 3 [7 mg of nicotine], no behavioral support provided). Participants randomized to the control group were not offered the nicotine patches or any other intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was 30-day smoking abstinence at 6 months. RESULTS: Of the 2093 participants who were interviewed as part of the baseline survey (76.5% response rate), 1000 were found eligible for the trial and randomized to a group. Analyses were conducted on 500 participants in the experimental group (mean [SD] age, 48.0 [12.8] years; 255 female [51.0%]) and 499 in the control group (mean [SD] age, 49.7 [12.7] years; 256 female [51.3%]). Self-reported abstinence rates were significantly higher among participants who were sent nicotine patches compared with the control group (30-day abstinence: 38 [7.6%] of 500 vs 15 [3.0%] of 499; odds ratio, 2.65; 95% CI, 1.44-4.89; P = .002). Usable saliva samples were returned by only 50.9% of the participants. Biochemically validated abstinence at 6 months was found in 14 (2.8%) of 500 participants in the experimental group vs 5 (1.0%) of 499 in the control group (odds ratio, 2.85; 95% CI, 1.02-7.96; P = .046). CONCLUSIONS AND RELEVANCE: The trial provides evidence of the effectiveness of mailed nicotine patches without behavioral support to promote tobacco cessation. The strength of these findings is tempered by the lack of biochemical validation for all participants. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01429129.