Trial reportBMC public health2016
A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation.
Trial report in BMC public health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02342795 (Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation), which is not on this map. Cited by 19 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
Who cites it
19 citing papers in PubMed, 8 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2026Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2024Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2022Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2021Pooled it
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2020Pooled it
- Trial
- Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction.Contemporary clinical trials · 2024Trial
- Changes in Nicotine Dependence Among Smokers Using Electronic Cigarettes to Reduce Cigarette Smoking in a Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023Trial
- Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers With No Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2022Trial
- Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial.The Lancet. Respiratory medicine · 2021Trial
- Measurement of Electronic Cigarette Frequency of Use Among Smokers Participating in a Randomized Controlled Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020Trial
- Pulmonary and other health effects of electronic cigarette use among adult smokers participating in a randomized controlled smoking reduction trial.Addictive behaviors · 2019Trial
- Biochemical Verification of Tobacco Use and Abstinence: 2019 Update.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2020Review
- Answering questions about electronic cigarettes using a multidisciplinary model.The American psychologist · 2019Article
- Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2016Review
- E-cigarettes for the management of nicotine addiction.Substance abuse and rehabilitation · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThis study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used.
methodsParticipants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. DISCUSSION: Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations.
trial registrationTRN: NCT02342795 , registered December 16, 2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.