BACKGROUND: The net benefit of aspirin cessation in older adults remains uncertain. This study aimed to use observational data to emulate a randomized trial of aspirin cessation versus continuation in older adults without cardiovascular disease (CVD).
METHODS: Post hoc analysis using a target trial emulation framework applied to the immediate post-trial period (2017-2021) of a study of low-dose aspirin initiation in adults aged ≥ 70 years (ASPREE; NCT01038583). Participants from Australia and the USA were included if they were free of CVD at the start of the post-trial intervention period (time zero, T0) and had been taking open-label or randomized aspirin immediately before T0. The two groups in the target trial were as follows: aspirin cessation (participants who were taking randomized aspirin immediately before T0; assumed to have stopped at T0 as instructed) versus aspirin continuation (participants on open-label aspirin at T0 regardless of their randomized treatment; assumed to have continued at T0). The outcomes after T0 were incident CVD, major adverse cardiovascular events (MACE), all-cause mortality, and major bleeding during 3, 6, and 12 months (short-term) and 48 months (long-term) follow-up. Hazard ratios (HRs) comparing aspirin cessation to continuation were estimated from propensity-score (PS) adjusted Cox proportional-hazards regression models.
RESULTS: We included 6103 CVD-free participants (cessation: 5427, continuation: 676). Over both short- and long-term follow-up, aspirin cessation versus continuation was not associated with elevated risk of CVD, MACE, and all-cause mortality (HRs, at 3 and 48 months respectively, were 1.23 and 0.73 for CVD, 1.11 and 0.84 for MACE, and 0.23 and 0.79 for all-cause mortality, p > 0.05), but cessation had a reduced risk of incident major bleeding events (HRs at 3 and 48 months, 0.16 and 0.63, p < 0.05). Similar findings were seen for all outcomes at 6 and 12 months, except for a lowered risk of all-cause mortality in the cessation group at 12 months.
CONCLUSIONS: Our findings suggest that deprescribing prophylactic aspirin might be safe in healthy older adults with no known CVD.

OBJECTIVE: The aim of this study was to compare past 12-month use of cigarette smoking cessation aids (e.g., Food and Drug Administration (FDA)-approved cessation products or e-cigarettes for smoking cessation) among people with substance use problems (PWSUPs) who currently smoke to people without substance use problems (SUPs) who currently smoke cigarettes in a nationally representative US sample.
METHODS: We used the Population Assessment of Tobacco and Health (PATH) Wave 6 Study [n = 30,516]. Our sample comprised adult (18+) established cigarette smokers (100+ lifetime-sticks with daily/non-daily use) [n = 5,895]. The independent variable was SUP status (no, moderate, and high). The dependent variables were past-year use of: nicotine replacement therapies (NRTs), cessation medications [i.e., varenicline or bupropion], or e-cigarettes [for cigarette cessation and reduction]. Weighted multivariable logistic regression models for each dependent variable examined the associations between SUP status and each cessation aid, adjusting for cigarette dependence, daily cigarette smoking, and demographic factors.
RESULTS: Among people who smoke, a higher proportion of respondents with high SUP severity used NRTs, cessation medications, and e-cigarettes for cigarette cessation, respectively (12.3%, 8.4%, 15.7%), compared to those with no/low SUP severity (9.8%, 6.0%, 8.9%). In the multivariable models, respondents with high SUPs had 63% (95% CI:1.16-2.29) higher odds of using e-cigarettes for cessation than those without SUPs. No significant differences were seen between high (vs. no/low SUPs) in the past-year use of NRTs and cessation medications.
CONCLUSIONS: Our findings indicate that cigarette smokers with high SUPs had higher odds of using e-cigarettes for cessation and reduction compared to smokers without SUPs.

BACKGROUND: Smokeless tobacco use remains prevalent in rural and medically underserved populations, leading to increased rates of tobacco-related cancers and chronic disease. While access to effective cessation programs is limited, text-based interventions may offer a delivery approach with broad reach. This two-armed randomized control trial (RCT) assessed the efficacy of #EnufSnuff.TXT, a text-based smokeless tobacco cessation intervention, in rural and medically underserved communities.
METHODS: We conducted a two-arm RCT assessing #EnufSnuff.TXT, a text-based scheduled reduction intervention paired with text-based cessation support messages compared with the modified Enough Snuff intervention comprised of a cessation education booklet and bi-weekly motivational text messages. We recruited participants via social media and surveyed participants at three and six months post-randomization. The primary outcome was self-reported seven-day point prevalence abstinence at six months.
RESULTS: We recruited and randomized 532 participants. At three months post randomization, the quit rate was significantly higher in #EnufSnuff.TXT arm compared to the Enough Snuff arm for intent-to-treat (ITT) cases (29.2% vs 19.0%, OR=1.75, p=0.0066). The quit rate at six months post randomization remained higher in #EnufSNuff.TXT compared to Enough Snuff for ITT cases (23.1% vs 20.9%, OR=1.14, p=0.5384), although no longer significantly different.
CONCLUSIONS: This is the first large-scale text-based cessation clinical trial for individuals in underserved areas who use smokeless tobacco. The #EnufSnuff.TXT intervention performed better in the short term, however both interventions yielded similar quit-rates at 6-months post randomization. Future research should focus on improving long-term abstinence in the #EnufSNuff.TXT intervention.
CONCLUSIONS: Text-based cessation approaches have the potential to increase access to cessation interventions in rural and medically underserved areas and reduce tobacco-related chronic disease morbidity and mortality. Our study shows short-term efficacy from the first ever randomized controlled trial of a smokeless tobacco cessation intervention, #EnufSnuff.TXT, for rural and medically underserved residents in the United States. Our #EnufSnuff.TXT Intervention offers a scalable solution to reach and provide much needed access to cessation interventions in medically underserved, rural communities in the United States. This work provides the foundation for further inquiry on augmented text-based approaches to increase cessation in this at-risk group.

OBJECTIVE: To pilot test QuitGuide for Natives, a culturally aligned version of the National Cancer Institute\'s QuitGuide smartphone app for smoking cessation.
METHODS: This randomised controlled trial was conducted remotely during 2022-2023. American Indian adults who smoked and resided in the Midwest (n=115) were randomised to QuitGuide for Natives or the general audience QuitGuide smartphone-based intervention. Group differences in feasibility (times the app was initiated), usability, acceptability (\'How likely would you be to recommend the app to a friend?\'), fit of app with culture and preliminary efficacy (24-hour quit attempts, cotinine-confirmed self-reported 7-day abstinence) outcomes were examined.
RESULTS: QuitGuide for Natives versus the general audience QuitGuide did not differ in the number of times the app was opened (adjusted incidence rate ratio 0.94 (95% CI 0.63 to 1.40); p=0.743) nor in usability score (adjusted mean difference (aMD) 0.73 (95% CI: -5.00 to 6.46); p=0.801) or likeliness of recommending the app to a friend (aMD 0.62 (95% CI -0.02 to 1.27); p=0.058). Differences were observed for all cultural fit outcomes such as \'The app fits my American Indian culture (aMD 0.75 (95% CI 0.35 to 1.16); p<0.001). QuitGuide for Natives versus the general audience QuitGuide resulted in an average of 6.6 vs 5.1 24-hour quit attempts (p=0.349) and cotinine-confirmed 7-day abstinence was achieved by 6.9% vs 3.5% (p=0.679).
CONCLUSIONS: Acceptability, cultural fit and preliminary efficacy findings are encouraging and will inform future, larger-scale evaluation of culturally aligned digital smoking cessation resources for American Indian adults.

BACKGROUND: Smoking is a well-known risk factor for cardiovascular diseases, including myocardial infarction (MI) and ischemic stroke (IS). While the relationship between smoking and the risk of cardiovascular diseases is established, the impact of changing smoking habits post-IS on the risk of subsequent MI remains unclear. This study aims to elucidate the effects of alterations in smoking behavior following an IS diagnosis on the likelihood of experiencing an MI.
METHODS: Utilizing data from the Korean National Health Insurance Services Database, this nationwide population-based cohort study included 199,051 participants diagnosed with IS between January 2010 and December 2016. Smoking status was categorized based on changes in smoking habits before and after IS diagnosis. The association between changes in smoking behavior and the risk of subsequent MI was analyzed using multivariable Cox proportional hazard regression models.
RESULTS: During a median follow-up of 4.17 person-years, a total of 5,734 (2.88%) patients were diagnosed with MI after IS. Smoking quitters (2.93%) or former smokers (2.47%) have a similar or lower rate of MI than the average, even if they have smoked cigarettes, while sustained smokers (3.46%) or new smokers (3.81%) have much higher rates of MI. Among sustained and new smokers, the risk of incident MI was significantly higher than never smokers (new smoker adjusted HR [aHR]: 1.496, 95% CI: 1.262-1.774; sustained smoker aHR: 1.494, 95% CI: 1.361-1.641). Also, among the study participants, approximately two-thirds continued smoking after their IS diagnosis.
CONCLUSIONS: Changing smoking habits after an IS diagnosis significantly influences the risk of subsequent MI. Specifically, continuing or starting to smoke after an IS diagnosis is associated with a higher risk of MI. These results underscore the importance of targeted smoking cessation interventions for stroke patients to reduce the risk of subsequent MI.

BACKGROUND: Conversational chatbots are an emerging digital intervention for smoking cessation. No studies have reported on the entire development process of a cessation chatbot.
OBJECTIVE: We aim to report results of the user-centered design development process and randomized controlled trial for a novel and comprehensive quit smoking conversational chatbot called QuitBot.
METHODS: The 4 years of formative research for developing QuitBot followed an 11-step process: (1) specifying a conceptual model; (2) conducting content analysis of existing interventions (63 hours of intervention transcripts); (3) assessing user needs; (4) developing the chat\'s persona (\"personality\"); (5) prototyping content and persona; (6) developing full functionality; (7) programming the QuitBot; (8) conducting a diary study; (9) conducting a pilot randomized controlled trial (RCT); (10) reviewing results of the RCT; and (11) adding a free-form question and answer (QnA) function, based on user feedback from pilot RCT results. The process of adding a QnA function itself involved a three-step process: (1) generating QnA pairs, (2) fine-tuning large language models (LLMs) on QnA pairs, and (3) evaluating the LLM outputs.
RESULTS: We developed a quit smoking program spanning 42 days of 2- to 3-minute conversations covering topics ranging from motivations to quit, setting a quit date, choosing Food and Drug Administration-approved cessation medications, coping with triggers, and recovering from lapses and relapses. In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to the National Cancer Institute\'s SmokefreeTXT text messaging program, particularly among those who viewed all 42 days of program content: 30-day, complete-case, point prevalence abstinence rates at 3-month follow-up were 63% (39/62) for QuitBot versus 38.5% (45/117) for SmokefreeTXT (odds ratio 2.58, 95% CI 1.34-4.99; P=.005). However, Facebook Messenger intermittently blocked participants\' access to QuitBot, so we transitioned from Facebook Messenger to a stand-alone smartphone app as the communication channel. Participants\' frustration with QuitBot\'s inability to answer their open-ended questions led to us develop a core conversational feature, enabling users to ask open-ended questions about quitting cigarette smoking and for the QuitBot to respond with accurate and professional answers. To support this functionality, we developed a library of 11,000 QnA pairs on topics associated with quitting cigarette smoking. Model testing results showed that Microsoft\'s Azure-based QnA maker effectively handled questions that matched our library of 11,000 QnA pairs. A fine-tuned, contextualized GPT-3.5 (OpenAI) responds to questions that are not within our library of QnA pairs.
CONCLUSIONS: The development process yielded the first LLM-based quit smoking program delivered as a conversational chatbot. Iterative testing led to significant enhancements, including improvements to the delivery channel. A pivotal addition was the inclusion of a core LLM-supported conversational feature allowing users to ask open-ended questions.
BACKGROUND: ClinicalTrials.gov NCT03585231; https://clinicaltrials.gov/study/NCT03585231.

BACKGROUND: Recent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors. However, research on associations among participant characteristics, intervention engagement, and outcomes is limited.
OBJECTIVE: This study aimed to explore the predictors and moderators of engagement and outcome of MyCourse-Quit Smoking (in Dutch: \"MijnKoers-Stoppen met Roken\"), a digital minimally guided intervention for cancer survivors.
METHODS: A secondary analysis of data from the randomized controlled trial was performed. The number of cigarettes smoked in the past 7 days at 6-month follow-up was the primary outcome measure. We analyzed interactions among participant characteristics (11 variables), intervention engagement (3 variables), and outcome using robust linear (mixed) modeling.
RESULTS: In total, 165 participants were included in this study. Female participants accessed the intervention less often than male participants (B=-11.12; P=.004). A higher Alcohol Use Disorders Identification Test score at baseline was associated with a significantly higher number of logins (B=1.10; P<.001) and diary registrations (B=1.29; P<.001). A higher Fagerström Test for Nicotine Dependence score at baseline in the intervention group was associated with a significantly larger reduction in tobacco use after 6 months (B=-9.86; P=.002). No other associations and no moderating effects were found.
CONCLUSIONS: Overall, a limited number of associations was found between participant characteristics, engagement, and outcome, except for gender, problematic alcohol use, and nicotine dependence. Future studies are needed to shed light on how this knowledge can be used to improve the effects of digital SC programs for cancer survivors.
BACKGROUND: Netherlands Trial register NTR6011/NL5434; https://onderzoekmetmensen.nl/nl/trial/22832.

OBJECTIVE: Smoking is an important modifiable risk factor in all vascular diseases and verbal advice from providers has been shown to increase rates of tobacco cessation. We sought to identify factors that will improve tobacco cessation and recall of receiving verbal cessation advice in vascular surgery patients at a single institution.
METHODS: The study is a retrospective cohort study. Patients seen in outpatient vascular surgery clinic who triggered a tobacco Best Practice Advisory (BPA) during their office visits over a 10-month period were contacted post-clinic and administered surveys detailing smoking status, cessation advice recall, and validated scales for nicotine dependence and willingness to quit smoking. This BPA is a \"hard stop\" that requires providers to document actions taken. Charts were reviewed for tobacco cessation documentation. Nine-digit zip-codes identified the area deprivation index, a measure of socioeconomic status. Univariate analysis was used to identify factors associated with cessation and advice recall.
RESULTS: One hundred out of 318 (31.4%) patients responded to the survey. Epic Slicer Dicer found 97 BPA responses. To dismiss the BPA, 89 providers (91.8%) selected \"advised tobacco cessation\" and \"Unable to Advise\" otherwise. Of the 318 patients, 115 (36.1%) had cessation intervention documented in their provider notes and 151 (47.5%) received written tobacco cessation advice. Of survey respondents, 70 recalled receiving verbal advice, 27 recalled receiving written advice, 28 reported receiving offers of medication/therapy for cessation. 55 patients reported having tobacco cessation plans, and among those 17 reported having quit tobacco. Recall of receiving written advice (P < .001) and recall of receiving medication/therapy (P = .008) were associated with recall of receiving verbal cessation advice.
CONCLUSIONS: Providing patients with tobacco cessation medication/therapy and written tobacco cessation education during office visits is associated with increased patients\' recall of tobacco cessation advice. Vascular surgeons should continue to provide directed tobacco cessation advice.

Background: Tobacco cannabis co-use is common and becoming more prevalent. Frequent and heavy users of cannabis may struggle to quit smoking. Quitlines offer free cessation treatment in the United States and 25% of quitline callers may also be cannabis users. The present paper describes a randomized pilot study of a tailored intervention for cannabis and cigarette co-users. The intervention combines the quitline smoking cessation treatment with a motivational enhancement therapy-based cannabis intervention. Methods: The randomized pilot study was conducted within four state-funded quitlines with quitline coaches as interventionists. 102 quitline callers who were cannabis and cigarette co-users were randomized to receive treatment as usual (TAU) or the new Quitline Check-Up (QLCU) intervention. Outcomes were collected 90 days post-randomization. Primary outcomes included feasibility and acceptability of delivering the QLCU in the quitline setting. Secondary outcomes included 7-day point prevalence tobacco abstinence, past 30-day cannabis use, and Cannabis Use Disorder Identification Test scores. Results: Study participants were heavy cannabis users, averaging 25 days of use in the past 30; nearly 70% used at a level considered hazardous. Fidelity ratings indicated coaches were successful at delivering the intervention. Treatment engagement was high for both groups (TAU m = 3.4 calls; QLCU m = 3.6 calls) as was treatment satisfaction. Intent-to-treat quit rates (with survey non-responders classified as smokers) were 28.6% for the TAU control group and 24.5% for the QLCU group (P = .45). Discussion: Hazardous cannabis use rates were high in this sample of tobacco cannabis co-users calling quitlines to quit smoking. The intervention for co-users was acceptable and feasible to deliver. No improvements in tobacco cessation outcomes were observed. Pragmatic intervention development within a real-world clinical setting can streamline the intervention development process. More research is needed on tobacco cannabis co-users and who can benefit from a tailored intervention. Registered: ClinicalTrials.gov NCT04737772, February 4, 2021.

UNASSIGNED: More than 70% of current smokers in Australia have a definite plan to stop smoking and around half of them try to quit every year. Latrobe Community Health Service (LCHS) was commissioned by Gippsland Primary Health Network to establish Latrobe Smoking Support Service (LSSS) to break down barriers to accessing services and increase support for smoking cessation. This research aims to assess the feasibility of an ongoing smoking cessation support service and determine the effect the LSSS has on client smoking behavior.
UNASSIGNED: Quantitative data were collected for the LSSS situated at LCHS during the period from September 2021 to March 2022. A new client survey, a returning client survey, and a 6-week follow-up survey were conducted by Clinic staff. The consent forms were obtained from the clients. A total of 117 clients attended the LSSS at least once, and a further 315 returning client sessions were conducted. The data analysis was undertaken by means of various descriptive and inferential statistical techniques, such as multiple linear regression analysis.
UNASSIGNED: The research findings demonstrate the strong positive effect of the LSSS in helping clients to change their smoking behavior. Results of multiple regression analysis highlight the significant role of behavioral intervention strategies in the LSSS\'s success. A combination of both nicotine replacement therapy (NRT) and counseling was a key contributor to the project\'s success.
UNASSIGNED: This research proposed and tested the model of a smoking cessation support service that combines a comprehensive mix of services for smokers including free NRT, free counseling, and ongoing support of counselors or/and nurse practitioners.