Dataset Information

Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial.

ABSTRACT: The potential for sampling bias in Internet smoking cessation studies is widely recognized. However, few studies have explicitly addressed the issue of sample representativeness in the context of an Internet smoking cessation treatment trial.The purpose of the present study is to examine the generalizability of participants enrolled in a randomized controlled trial of an Internet smoking cessation intervention using weighted data from the National Health Interview Survey (NHIS).A total of 5290 new users on a smoking cessation website enrolled in the trial between March 2012 and January 2015. Descriptive statistics summarized baseline characteristics of screened and enrolled participants, and multivariate analysis examined predictors of enrollment. Generalizability analyses compared demographic and smoking characteristics of trial participants to current smokers in the 2012-2014 waves of NHIS (n?=?19,043) and to an NHIS subgroup based on Internet use and cessation behavior (n?=?3664). Effect sizes were obtained to evaluate the magnitude of differences across variables.Predictors of study enrollment were age, gender, race, education, and motivation to quit. Compared to NHIS smokers, trial participants were more likely to be female, college educated, and daily smokers and to have made a quit attempt in the past year (all effect sizes 0.25-0.60). In comparisons with the NHIS subgroup, differences in gender and education were attenuated, while differences in daily smoking and smoking rate were amplified.Few differences emerged between Internet trial participants and nationally representative samples of smokers, and all were in expected directions. This study highlights the importance of assessing generalizability in a focused and specific manner. CLINICALTRIALS.GOV: #NCT01544153.

SUBMITTER: Cha S

PROVIDER: S-EPMC5055432 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial.

Cha Sarah S Erar Bahar B Niaura Raymond S RS Graham Amanda L AL

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20161001 5

<h4>Background</h4>The potential for sampling bias in Internet smoking cessation studies is widely recognized. However, few studies have explicitly addressed the issue of sample representativeness in the context of an Internet smoking cessation treatment trial.<h4>Purpose</h4>The purpose of the present study is to examine the generalizability of participants enrolled in a randomized controlled trial of an Internet smoking cessation intervention using weighted data from the National Health Interv ...[more]

PMID: 27283295

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Project description:Importance:It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia. Objective:To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles. Design, Setting, and Participants:The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018. Main Outcomes and Measures:Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported. Results:A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging. Conclusions and Relevance:The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD. Trial Registration:ClinicalTrials.gov Identifier: NCT01471522.

Project description:AimsTo evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone. The text message intervention was optimized for engagement in an earlier multiphase optimization (MOST) screening phase.DesignA parallel, two-group, individually randomized clinical trial (RCT) was conducted in a MOST confirming phase. Recruitment spanned December 2018 to March 2019. Follow-up was conducted at 3 and 9 months, beginning March 2019 and ending January 2020.SettingUnited States: a digital study conducted among new registrants on a free tobacco cessation website.ParticipantsEligible individuals were 618 adult current smokers in the United States, age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white).InterventionsThe treatment arm (WEB+TXT; n = 311) received access to the website and text messaging. The control arm (WEB; n = 307) received access to the website alone.MeasurementsThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking. Secondary outcomes included 3-month measures of 30-day ppa, intervention engagement and intervention satisfaction.FindingsAbstinence rates at 9 months were 23.1% among WEB+TXT and 23.2% among WEB (OR = 1.00, 95% CI = 0.69-1.45; P = 0.99). WEB+TXT increased engagement with 5 of 6 interactive features (standardized mean difference (SMD) = 0.26-0.47, all P < 0.001) and repeat website visits (48.7% vs 38.9%, SMD = 0.14, P = 0.02). Satisfaction metrics favored WEB+TXT (satisfied: 96.3% vs 90.5%, SMD = 0.17, P = 0.008; recommend to friend: 95.9% vs 90.1%, SMD = 0.16, P = 0.028).ConclusionsA randomized controlled trial found no evidence that a combined internet and text message intervention for smoking cessation compared with an internet intervention alone increased 9-month abstinence rates among adult current smokers in the United States, despite evidence of higher levels of intervention engagement and satisfaction at 3 months.

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Dataset Information

Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial.

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Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial.

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